Panels › Physical Medicine › Product code BXB · Class 1
Exerciser, Powered
Regulation 890.5380
0510(k)s in 12 months (160 all time)
0recalls in 12 months (6 all time)
1recalls that name a 510(k)
Top companies in BXB
| Company | 510(k)s | Recalls |
|---|---|---|
| Allied Associates, Inc. | 9 | 0 |
| Toronto Medical Corp. | 9 | 0 |
| Buckman Co., Inc. | 8 | 0 |
| Invacare Corp. | 8 | 0 |
| Sutter Corp. | 5 | 0 |
| Dyna Flex, Intl. | 4 | 0 |
| Sutter Biomedical, Inc. | 4 | 0 |
| Baltimore Therapeutic Equipment Co. | 3 | 0 |
| Biodex Medical Systems, Inc. | 3 | 0 |
| Danninger Medical Technology, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 25, 2008 | K072887 | G-TRAINER MEDICAL Alter-G, Inc. | BXB |
| Apr 4, 2001 | K003272 | FLO-BOOT Discovery Group, LLC | BXB |
| Sep 25, 1996 | K952975 | ANKLE CALF EXERCISER PHLEBOPUMP Prevent Products, Inc. | BXB |
| Jan 26, 1996 | K953456 | E-Z FLEX Fluid Motion Biotechnologies, Inc. | BXB |
| Dec 29, 1995 | K955106 | BTE CPM-20 Baltimore Therapeutic Equipment Co. | BXB |
| Dec 29, 1995 | K955105 | BTE CPM-10 Baltimore Therapeutic Equipment Co. | BXB |
| Dec 11, 1995 | K951028 | HAMEX TWO Northern Orthopaedic Products, Inc. | BXB |
| Oct 5, 1995 | K950755 | FLEXMATE K500 Breg, Inc. | BXB |
| Sep 15, 1995 | K951029 | HAMEX ONE Northern Orthopaedic Products, Inc. | BXB |
| Sep 15, 1995 | K945733 | AQUAHAB, MODEL 120-72-101 Aquarius Electronics, Inc. | BXB |
| Sep 13, 1995 | K950682 | W2 WRIST CPM UNIT Toronto Medical Corp., CA | BXB |
| Aug 7, 1995 | K952369 | KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE Physicians Consulting, Inc. | BXB |
| Jun 22, 1995 | K945690 | BACKCYCLER CPM(TM) Ergomedics, Inc. | BXB |
| Jun 15, 1995 | K946169 | ACTIC 2002 North Atlantic Rehabilitation, Inc. | BXB |
| Apr 5, 1995 | K945824 | GALAXY MD SERIES THERAPYPOOLS Galaxy Aquatics, Inc. | BXB |
| Mar 10, 1995 | K944819 | KRDL 2000 Physicians Consulting, Inc. | BXB |
| Feb 27, 1995 | K945221 | SUTTER MODEL 6000 HAND CPM DEVICE Sutter Corp. | BXB |
| Feb 17, 1995 | K945121 | A3 ANKLE CPM UNIT Toronto Medical, Inc. | BXB |
| Jan 12, 1995 | K940455 | LATERAL FLEXION MACHINE Rehab, Inc. | BXB |
| Jan 9, 1995 | K935011 | SWIMEX MULTIDEPTH POOL (MODEL 600T) Swimex Systems | BXB |
| Dec 14, 1994 | K935587 | MULTILINK SHOULDER CPM UNIT Toronto Medical Corp., CA | BXB |
| Oct 3, 1994 | K935509 | HYDROTRACK Ferno Ille | BXB |
| Sep 16, 1994 | K935520 | UPPER BODY CYCLES (110 VOLT)/(220 VOLT) Biodex Medical Systems, Inc. | BXB |
| Sep 16, 1994 | K935216 | SEMI-RECUMBENT CYCLES Biodex Medical Systems, Inc. | BXB |
| Sep 16, 1994 | K935061 | LOWER BODY CYCLES Biodex Medical Systems, Inc. | BXB |
| Jun 22, 1994 | K942618 | ANKLE CALF EXERCISER Prevent Products, Inc. | BXB |
| Jun 22, 1994 | K933059 | ARTROMOT-E, ELBOW / ARTROMOT-S, SHOULDER CMP MOD. Jace Systems, Inc. | BXB |
| May 20, 1994 | K926136 | WATSYSTEM Watsystem Div. of Itc | BXB |
| May 6, 1994 | K931128 | BASIC SHOULDER CPM Danninger Medical Technology, Inc. | BXB |
| Apr 19, 1994 | K935467 | R & D BATTERIES, INC. PART NUMBER 5447 R & D Batteries, Inc. | BXB |
| Mar 24, 1994 | K935188 | STRETCHPOWER Orthopedic Development, Inc. | BXB |
| Mar 24, 1994 | K934175 | STRETCHPOWER(TM) BRAND OF STRETCH LOADING EXERCISER Orthopedic Development, Inc. | BXB |
| Mar 18, 1994 | K935808 | REVOLUTION LOWER LIMB CPM UNIT Toronto Medical, Inc., CA | BXB |
| Mar 11, 1994 | K933394 | DANNIFLEX CPM 600 Danninger Medical Technology, Inc. | BXB |
| Feb 17, 1994 | K930780 | ADV400 TOE CPM Advanced Kinetics, Inc. | BXB |
| Feb 4, 1994 | K926313 | COMPUTERIZED TESTING AND EXERCISE SYSTEMS Henley Intl. | BXB |
| Jan 31, 1994 | K931555 | ARTROMOT K2 CPM Ormed Mfg., Inc. | BXB |
| Jan 27, 1994 | K931736 | M-FLEX 5000 C3PMD Medical Systems Corp. | BXB |
| Jan 26, 1994 | K933311 | MOTORIZED ELECTRIC PARALLEL BARS Midland Mfg. Co. | BXB |
| Jan 26, 1994 | K931723 | HYDRO-TRED/AIR POWERED TREADMILL Santa FE Swim Systems | BXB |
| Jan 26, 1994 | K926262 | FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE Sgarlato Laboratories, Inc. | BXB |
| Jul 21, 1993 | K925270 | EX N' FLEX EF-200 Tecogics Scientific , Ltd., CA | BXB |
| Mar 31, 1993 | K925977 | PARAMED FLEXION-EXTENSION MACHINE Paramed Services, Inc. | BXB |
| Mar 31, 1993 | K925271 | REPEX-REPEATED ENDRANGE PASSIVE EXERCISE MACHINE Repex Intl., Inc., NZ | BXB |
| Mar 31, 1993 | K924513 | LIDO(R) LINEA Loredan Biomedical, Inc. | BXB |
| Mar 24, 1993 | K925807 | AQUACISER IN-POOL TREADMILL Aquaciser, Inc. | BXB |
| Mar 22, 1993 | K925926 | MOBILIMB T1 TOE CPM UNIT Toronto Medical Corp., CA | BXB |
| Mar 22, 1993 | K924484 | ARTROMOT MULTI DIRECTIONAL ANKLE CPM Buckman Co., Inc. | BXB |
| Mar 9, 1993 | K925666 | THERAPACER 3000 Kvm Technologies, Inc. | BXB |
| Feb 22, 1993 | K924654 | FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT Sutter Corp. | BXB |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.